A community based study to assess the role of Ayurvedic interventions and lifestyle advocacy on Iron Deficiency Anemia in women of reproductive age in Chengalpattu district of Tamilnadu
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,120
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin level
研究概览
简要总结
The present study is conducted to assess the role of Ayurvedic Interventions and Lifestyle advocacy on Iron Deficiency anemia in women of reproductive age in a selected district in Tamil Nadu. It is a single arm study in which willing reproductive-age women (15 to 49 years age) will be enrolled. It will be carried out in 1120 participants and the total duration of study will be 3 years. Ayurvedic Medicines viz, Punarnavadi Mandura and Dadimadi Ghritha and lifestyle advocacy will be adviced to follow for 90 days. The primary outcome will be change in Hemoglobin level which will be assessed during baseline, 90th day and 180th day. Secondary outcomes include change in blood indices such as RBC Count, MCV, MCHC, and PCV, Change in Serum ferritin, Medication adherence and compliance to lifestyle advocacy and documentationof demographic characteristics and severity ofanemiathrough pre-designed questionnaire to assess the association between both.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Non-pregnant non-lactating women of reproductive age(15 to 49years),Hb greater than or equal to 8 gm percentage and less than 12 gm percentage,intend to remain in the study site for the next 6 months atleast, willingness to sign the informed consent form(Written assent in participants below 18 years of age) and to participate in the study related activities such as adherence to lifestyle advocacy,study intervention, logging in compliance log, etc.
排除标准
- •Severe anemia(less than 8gm percentage) warranting immediate referral and care, history of diagnosis of other types of anemia, Women with menstrual irregularities such as menorrhagia, irregular menstrual cycles, cycle duration less than 24 days, History of any chronic or other medical condition (e.g. IBS, IBD, malignancy) requiring frequent medical attention or potentially interfering with nutritional status, malnutrition warranting medical attention, Obesity (BMI greater than or equal to 29.9),any chronic or acute illness that require intake of any other medications other than oral hypoglycemic agents or anti-hypertensive, any other condition that, as per the PI would adversely affect participation in the study or the outcome of the study.
结局指标
主要结局
Change in Hemoglobin level
时间窗: To be assessed during baseline,90thday and 180th Day
次要结局
- 1.Change in the other blood indices such as RBC Count, MCV, MCHC, and PCV(2.Change in Serum Ferritin level)